Newsletter | January 19, 2022

01.19.22 -- Outsourcing For Duchenne: Techniques For All Biopharma

From The Editor
Featured Editorial
Industry Insights
Benefits Of RABS And Isolator Technology In A Changing Regulatory Landscape

Restricted access barrier systems (RABS) or isolator technologies represent an integral component of a manufacturer’s quality control strategy. The current regulatory landscape requires drug manufacturers to employ a RABS or isolator as part of their risk mitigation approach, and companies looking to develop in-house capabilities or contract to a CDMO should understand the key elements of each to make the best, most informed decision for their product.

Oxygen-Sensitive Drug Products

Primary packaging is thought of as the first line of defense against the negative effects of oxygen. This article highlights other areas to consider that can help avoid drug quality degradation.

Selecting A CMO Partner For Sterile Injectable Manufacturing
Performing the transfer of a product or technology from a small-scale development process to full-scale commercial manufacturing can be difficult; but vetting for the right CMO partner can pose its own challenges.
How CDMO Flexibility In Upstream Production Improves Speed-To-Market

To provide the best service, a CDMO's facility should be equipped with flexible manufacturing platforms that can be adjusted for multiple customers while also mitigating risk.

Taking Biotherapeutic Candidates From Late Discovery To The Clinic

Many initially promising biotherapeutic candidates fail due to lack of efficacy or safety, but there are candidates that fail due to stability, aggregation, and other issues related to cell line or process issues. 

Technical Considerations For Developing Oral Solids (Part 2)

In the second installment of this series, experts from Pfizer CentreOne’s global network and partner organizations consider the effects of equipment design and different tablet strategies.

Biologics Development, Manufacturing, And Packaging Roundtable

A panel of experts discussed challenges and opportunities related to the development, clinical phases, and commercialization of biologics. They also offered insights on how to improve sponsor-CDMO relationships.

Five Ways To Get To IND/IMPD Faster

How do you get to IND/IMPD without sacrificing quality and future commercialization goals? Expert considerations for accelerating and optimizing your early development process.

Placing Drug Strategies On A Solid Foundation For Success

Examine the trends influencing pharmaceutical development and manufacturing strategy and how these drivers are impacting outsourced development and manufacturing strategies.

Navigating Bioconjugate Development: A Q&A

Iwan Bertholjotti, director of commercial bioconjugate development, and Dr. Bernhard Stump, head of bioconjugate development, discuss complexity and uncertainty in the bioconjugates market.

Collaborating Strategically And Leveraging Innovation To Drive Success

Senior vice president for business development Federico Pollano explains how the company is leveraging its 50-year experience and dual sites in Germany and the United States to flexibly meet market demand.

Does Your Clinical Trial Design Satisfy The Needs Of Your Patients?

While the patient-centric design of decentralized trials increases convenience and provides an uninterrupted flow of medication for the patient, it can also positively impact trial enrollment and retention for sponsors.

Biologics Drug Product: Formulation, Tech Transfer, Delivery Strategies

Review key considerations for formulation screening of therapeutic proteins and how consistency, planning, and communication are essential for a successful biologics drug product tech transfer.

Outsourced Pharma Content Collections
Your Supply Chain On Inflation: An Outsourcing Analysis

Outsourced Pharma chief editor Louis Garguilo has been an ahead-of-the-curve chronicler of inflation in the development and manufacturing supply chain. Based on interviews with biopharma professionals — from CEOs to frontline workers and consultants — he’s kept readers informed of rising outsourcing challenges, including the price for materials and services at CDMOs and hard-to-find capacity as supply chains remain strained. Now we’ve collected four of Garguilo’s editorials with outsourcing professionals to help you understand what they and the entire industry is experiencing, what you can expect in 2022, and some steps you might be able to take to mitigate these market forces.